ABOUT THIS GUIDE This Guide provides a high-level overview of in and how they can be used to help identify clinically appropriate and approvable patients who may be candidates for PRALUENT (alirocumab) therapy based on the approved Indication. The overview is meant to provide guidance for you, your practice electronic health record (EHR) champion, or IT staff. Experienced users are the main focus of this Guide; not every step is included in the instructions, and this is not a replacement for training from. There are several ways to approach each workflow in. This Guide highlights one workflow; however, you may be familiar with an alternative approach. Please note that this Guide was created based upon version 16.0. Screens and features may change as new software versions are released. INDICATIONS AND USAGE PRALUENT is a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT. Reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization
Using The Report can be helpful to identify Atherosclerotic Cardiovascular Disease (ASCVD) or Heterozygous Familial Hypercholesterolemia (HeFH) patients meeting certain criteria, including diagnosis, current and prior medications, LDL-C values, and other clinical or patient demographic information. When used effectively, this report provides an opportunity to identify patients with uncontrolled LDL-C who are clinically appropriate and approvable for PRALUENT therapy based upon clinician decision to treat. A Report can be used to streamline the PRALUENT payer approval process by: Determining clinically appropriate and approvable patients based on payer utilization management criteria Reducing burden and frustration of submitting patients who are not prior authorization (PA) criteria-eligible based on the payer coverage Identifying gaps-in-care to contact patients who may be considered for treatment modification Report Criteria can be created from multiple criteria such as lab values, medications, and patient diagnoses. For example, EHR criteria could include patients with clinical ASCVD, being on maximally tolerated statin therapy atorvastatin 40 mg/day and having elevated LDL-C 70 mg/dl or 100 mg/dl, depending on insurance. Factors That May Impact The number of patients appearing on a Report may be impacted by the clinical data available in the EHR; for example, if lab results are saved in the EHR as a PDF file and not available for use as `data to be queried. Additionally, in those cases where lab results are received from multiple laboratories, it may be necessary to select each lab s order codes to enable all appropriate patients to appear on the Report. The query criteria should consider active patients only (not deceased or inactive as determined by the practice). Also, medications prescribed before the EHR was implemented might not be included in a patient s medications list. These information gaps can reduce the number of patients on a Report. Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve
Reporting: Creating a Report A List, called a Report in, is an EHR system report that identifies all patients meeting certain criteria. Available criteria include diagnosis, current and prior medications, lab values, and other clinical or patient demographic information. A report may be created to identify patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease who are not at their LDL-C goal who are currently on maximally tolerated statin therapy. The following steps illustrate how to run a Report to help identify examples of appropriate patients for PRALUENT, based on the approved indication, who may be candidates for treatment intensification in. REPORTING: CREATING A PATIENT LIST 1. From File Menu: Select > Generate Report > By Practice. 2. Select from the Settings List. Click the ellipsis to set appropriate diagnosis filters (Clinical ASCVD [eg, stroke, transient ischemic attack, acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, peripheral arterial disease] plus hypercholesterolemia OR HeFH). Report Filter: Settings List Search Filter Filter Active/Inactive Descriptions All Date Onset Date Diagnosed Date Resolved Chart Note Chronic Date Time Status Severity No known Number of 0 Detail Summary Report List Add Sub Report Options Head/Foot Ok Cancel Save The most commonly occurring adverse reactions ( 5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza
Reporting: Creating a Report 3. Select from the Settings List. 4. From the Search tab, click the ellipsis to set appropriate medication criterion (eg, atorvastatin, rosuvastatin). Report Filter: Settings List Search Filter Chart Brand Name Generic Name Dose Route Desc Med Cat Desc Start Date Med Cat Desc Start Date Severity Rx Refills Duration Rx Quantity Rx Units PRN Reason Sample Lot Number Exp M Y DEA Level Limit Renewals Med Prescribe Elsewhere Prescribing Prior Authorization Prescribing Location Dispense As Written Number of s No Active s Audit Type All 0 Detail Summary Report List Add Sub Report Options Head/Foot Save Ok Cancel 5. Click OK. Local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo
Reporting: Creating a Report Report Filter: Settings List Fields Search Template Name Select Field 6. Select. 7. Search for Lab Results in Template Name. Select the appropriate Field (LDL-C) in Select Field. NOTE: must be set up in advance by the practice. Not all practices use, and not all practices have Lab Results. 8. Select Filter from the Settings List. Select parameter for Lab Result and parameter for Greater Than. Add Filter Chart lab results Select Template Template Name P Lipid_Clinic_Data Lipid_Clinic_ref Lipid_FollowUp P Lipid_FU_Labs lipid_lab_extpop P Lipid_lab_results lovenox_mr_pop LExtPop male_uro_qv_aplan male_uro_qv_subj Manage_HCC_Codes mandated_care_co Convert to Numeric All Selected Tables must have a record Head/Foot Save P Lipid_lab_results_create_timestamp P Lipid_lab_results_modify_timestmap P Lipid_lab_results_cpk_date P Lipid_lab_results_desc Lipid_lab_results_cpk_flag P Lipid_lab_results_cpk_range Lipid_lab_results_cpk_units Lipid_lab_results_creat_date Lipid_lab_results_creat_desc Lipid_lab_results_creat_flag Lipid_lab_results_creat_range Lipid_lab_results_creat_units Lipid_lab_results_crp_date P Lipid_lab_results_crp_desc Lipid_lab_results_crp_flag Latest Value By: None Report List OK Add Sub Report Cancel appropriate value (ie, 70 mg/dl or 100 mg/dl, depending on insurance). 9. Select OK to save filters. Run the report. Report Filter: Settings List In, lab results may not be available in reporting criteria. Lab result reporting may be able to be generated from a lab vendor reporting system. Filter Chart Lipid_lab_results_create_timestamp Lipid_lab_results_modify_timestamp AND Lipid_lab_results_cpk_date AND Lipid_lab_results_cpk_desc AND Lipid_lab_results_cpk_range AND Lipid_lab_results_crp_desc AND Equal Not Equal Greater Than Contains IN Not IN / / / / Entries No Field Value Time Period Entries Select Field Time Period From: To: None From: Time Between Entries To: Detail Summary Report List Add Sub Report Options Head/Foot Save OK Cancel The once-monthly (Q4W) 300mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively) in a trial in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind. The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms
INDICATIONS AND USAGE PRALUENT (alirocumab) is a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT. Reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve The most commonly occurring adverse reactions ( 5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza Local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo The once-monthly (Q4W) 300mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively) in a trial in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind. The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms Neurocognitive events were reported in 0.8% of patients treated with PRALUENT and 0.7% of patients treated with placebo. Confusion or memory impairment were reported more frequently by those treated with PRALUENT (0.2% for each) than in those treated with placebo (<0.1% for each) Liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%) PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT 2017 Sanofi and Regeneron Pharmaceuticals, Inc. All rights reserved. April 2017 US.ALI.17.03.067 US-PCS-13798